دواعي استعمال رانيكسا 750مجم 60 قرص ممتد المفعول

Ranolazine 750 mg prolonged-release tablets, box of 60 (3 strips) (Menarini > Medsites, Egypt); antianginal add-on therapy.

• Add-on therapy in adults for the symptomatic treatment of stable angina pectoris in patients inadequately controlled by, or intolerant to, first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).الفئة: Adultselectronic medicines compendium (emc)

• Common: dizziness, headache, constipation, vomiting, nausea, asthenia.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Uncommon include anorexia, anxiety, insomnia, confusion, hallucination, syncope, somnolence, tremor, blurred vision, diplopia, vertigo, tinnitus, hypotension, dyspnoea, abdominal pain, dry mouth, dyspepsia, pruritus, muscle cramp, dysuria, haematuria, peripheral oedema, increased blood creatinine/urea and prolonged QTc. Rare include hyponatraemia, pancreatitis, angioedema and acute renal failure.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Hypersensitivity to ranolazine or any excipient.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Severe renal impairment (creatinine clearance < 30 ml/min); moderate or severe hepatic impairment.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Concomitant potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazole, posaconazole, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone).نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Concomitant Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Use caution when increased exposure is expected: moderate CYP3A4 inhibitors, P-gp inhibitors, mild hepatic impairment, mild-moderate renal impairment, elderly, body weight <= 60 kg, moderate-severe heart failure (NYHA III-IV); risk is higher in CYP2D6 poor metabolisers.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Ranolazine prolongs the QTc interval in a dose-related manner; use caution in congenital or family history of long QT syndrome, acquired QT prolongation, or with drugs affecting QTc.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Should not be used with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's Wort) because of expected lack of efficacy.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• May cause dizziness, blurred vision, diplopia, confusional state, abnormal coordination or hallucination, which may affect driving and use of machines.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Potent CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, HIV protease inhibitors, grapefruit juice)Increase ranolazine exposure (ketoconazole 3.0-3.9-fold AUC); potent inhibitors are contraindicated.electronic medicines compendium (emc)
• Diltiazem, erythromycin, fluconazole (moderate CYP3A4 inhibitors)Diltiazem raises ranolazine steady-state levels 1.5-2.4-fold; careful titration, down-titration may be needed.electronic medicines compendium (emc)
• Verapamil, ciclosporin (P-gp inhibitors)Verapamil increases ranolazine levels 2.2-fold; careful titration recommended.electronic medicines compendium (emc)
• Rifampicin and other CYP3A4 inducersRifampicin decreases ranolazine levels by about 95%; avoid initiating ranolazine with inducers.electronic medicines compendium (emc)
• SimvastatinSimvastatin exposure about doubled; rhabdomyolysis reported; limit simvastatin to 20 mg once daily.electronic medicines compendium (emc)
• DigoxinDigoxin levels increased about 1.5-fold; monitor digoxin levels.electronic medicines compendium (emc)
• Metformin (OCT2 substrates)Metformin exposure increased 1.4-fold with ranolazine 500 mg twice daily and 1.8-fold with 1000 mg twice daily.electronic medicines compendium (emc)
• Tacrolimus, ciclosporin, sirolimus, everolimusIncreased concentrations; monitor blood levels and adjust dose.electronic medicines compendium (emc)
• Metoprolol and other CYP2D6 substratesRanolazine 750 mg twice daily increased metoprolol levels 1.8-fold; lower doses may be required.electronic medicines compendium (emc)
• QT-prolonging drugsTheoretical additive risk of ventricular arrhythmias.electronic medicines compendium (emc)

• Limited human data; animal studies showed embryotoxicity. Should not be used during pregnancy unless clearly necessary.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Unknown whether excreted in human milk (excreted in rat milk); should not be used during breast-feeding.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Check renal function at regular intervals during treatment.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)
• Monitor digoxin levels after starting and stopping ranolazine; monitor tacrolimus (and other narrow-therapeutic-range CYP3A4 substrates) blood levels.نشرة دولية لنفس التركيبة · electronic medicines compendium (emc)

• Mechanism largely unknown; may act by inhibiting the late sodium current in cardiac cells, reducing intracellular sodium and consequent calcium overload during ischaemia, without depending on changes in heart rate, blood pressure or vasodilation (UK Ranexa SmPC).